St. Louis-based Certara, which was formed through the merger
of scientific software providers Tripos and Pharsight, is a provider of drug
discovery and development software. U.K.-based Simcyp is a research company
that provides a modeling and simulation platform for predicting the fate of
drugs in virtual populations, including pediatric populations.

In making the announcement, Certara President and CEO Jim
Hopkins says the capabilities offered by Simcyp's preclinical technologies,
combined with Certara's existing software products and scientific consulting
services, "will provide significant drug development advantages to our mutual
and prospective clients."

"From a translational science perspective, Simcyp's
preclinical simulation technologies, which include prediction of drug-drug
interactions, fit perfectly between Certara's existing discovery and clinical
research offerings, thus enabling an end-to-end solution," he adds. "For
example, this means broader capabilities to predict drug disposition as a function
of molecular structure, and the ability to utilize a single unified suite of
tools to facilitate preclinical and clinical PB/PK and PK/PD modeling and
analysis."

John Evans, managing director at Simcyp, says the
acquisition by Certara will allow Simcyp to focus on its core competence while
drawing on the broader drug development expertise available within the Certara
family.

"Clients from across the spectrum of drug discovery and
development will have access to an expanded and integrated range of products
and services, which will be enhanced by combining the attributes of Tripos,
Simcyp and Pharsight science and functionality," he says.

According to Daniel L. Weiner, Certara's senior vice
president and general manager of software, the buyout builds on Certara's
Tripos software used in drug discovery and its Pharsight solution for users
conducting preclinical and clinical drug research.

"Simcyp is an ideal fit between Certara's existing
technology in molecular modeling and QSAR from Tripos and PK/PD modeling from
Pharsight, making Certara the only company that has predictive science methods
in discovery, preclinical and clinical drug research, along with an R&D
informatics solution to integrate data across all domains," he says.

Many drug development organizations are looking for ways to
integrate the currently divided silos in research and development and to
improve decision-making between and among discovery, preclinical and clinical
providers.

The Simcyp Simulator is a physiologically based
pharmacokinetic simulation tool, known as PB/PK simulation. It is primarily
used by preclinical teams to predict key clinical decisions around drug safety,
ADME and drug-drug interactions.

Weiner adds that the addition of Simcyp's technologies
allows Certara "to create in-silico
workflows that reduce the need for costly and time-consuming lab and clinical
work by focusing experimental effort only on compounds with the desired PK,
safety and efficacy, thus improving yields throughout the process."

Geoff Tucker, chairman of Simcyp, points out that the
accuracy of in-vitro/in-vivo
extrapolation depends on the inclusivity and quality of the input data for a
particular compound.

"With good data, the prediction, for example, of the extent
of drug-drug interactions, is of the order of 80 percent within a factor of
two," he explains. "Extensive performance verification both within Simcyp and
externally through the experience and publications of its consortium members has
provided significant confidence in the approach."

Moreover, as a testament to the impact of PB/PK modeling in
drug development, Tucker notes that the current draft of the U.S. Food and Drug
Administration Guidance for Industry on Drug-Drug Interactions provides strong
endorsement of the approach, indicating that simulation can be used as a basis
for waiving real studies when the predicted extent of an interaction is small.

The acquisition by Certara means that Simcyp will continue
to operate as before, developing algorithms and databases, providing extensive
education on PB/PK-PD modeling through its workshops and offering high-level
consultancy.

Tucker adds that there will now be considerable effort to
align and integrate its products with those of Tripos (linkage of exposure to
target and off-target effects) and Pharsight (linkage through to Phoenix
WinNonlin and NLME and the Clinical Trials Simulator).

Weiner says the goal of this acquisition is to position
Certara as the leading provider of tools and an informatics infrastructure to
support translational drug development.

"The success will be measured by clients' willingness to
invest in the solution we are providing," he says.